Board meeting minutes: 9 December 2004

Friday 11 February 2005

Congress Centre, Great Russell Street, London, WC1B 3LS

Open session 9:30 ' 12:40

Present:
Sir John Krebs, Chairman
Julia Unwin, Deputy Chair
Richard Ayre
Sati Ariyanayagam
Chrissie Dunn
Maureen Edmondson
Michael Gibson
Ann Hemingway
Valerie Howarth
Iain MacDonald
Andrew Miller
Vernon Sankey
Sandra Walbran
Nelisha Wickremasinghe

Officials attending:
Jon Bell ' Chief Executive
Chris Lawson ' Chief Executive (MHS) (items 4, 5 and 7 only)
Peter Hewson ' Deputy Veterinary Director (item 4 only)
David Carruthers ' Head of Over Thirty Months (OTM) Branch (item 5
only)
Alan Harvey ' Head of Transmissible Spongiform Encephalopathies
(TSE) Division (item 6 only)
Keith Gregory ' Board Secretary
Barbara Gallani ' Board Secretariat

Others attending:
Patrick Wall ' University College Dublin and Chair of the Steering Group asked to oversee the Independent Inquiry into the failure of the Meat Hygiene Service to test casualty cattle for BSE (items 4 and 5 only)

Chairman's Introduction

1. The Chairman reminded Board members of their obligation to declare interests before discussion of relevant items.

2. There was one item raised for discussion under Any Other Business:

• Update on delivering the Agency's Research Strategy ' Information Paper INFO 04/12/01 (Michael Gibson).

Item 1 - Minutes of the Meeting on 14 October, Belfast (Paper FSA 04/12/01)

3. The Board agreed the Minutes of the meeting held on 14 October at the Hilton Hotel, Belfast as an accurate record.

4. In considering matters arising and the table of follow up action, the following issues were raised:

• One Board member asked why the action arising from paragraph 8 of the minutes had not been recorded formally in the table of follow up action. The Chairman, noting this to be the case, confirmed that the evaluation of the impact of the FSA's salt campaign in raising awareness was shortly to be circulated to all Board members.
  Action:Secretariat
• Index 91, p.18: The Chairman informed Board members that the final report on research on M.bovis in tissues from animals with localised disease had been completed. An information paper addressing the implications of this report for meat safety would be circulated to the Board before the end of December 2004 and would be published on the FSA's website.

Item 2 - Chairman's Report

Hampton Review

5. The Chairman reminded Board members that Philip Hampton had been invited by the Chancellor of the Exchequer to lead a review to consider the scope for promoting more efficient approaches to regulatory inspection and enforcement while continuing to deliver excellent regulatory outcomes. In its interim report, published on 2 December 2004 , the Hampton review team had not made any recommendations but had set out some areas to be developed before the publication of the final report (simultaneously with the 2005 Budget), and some proposals for public consultation. The proposals of most interest to the FSA include the possibility of consolidation of regulatory functions in government and suggestions that the FSA's remit be extended to include aspects of medicines, drinking water and pesticides. The Chairman asked Board members whether they wanted to propose any criteria in addition to those already suggested by others . Board members would have a further opportunity to discuss and develop these criteria before the final response to the consultation was formulated and submitted in time to meet the review team's deadline of 4 February 2005.

6. Board members agreed that any criteria should reflect the ability of the FSA to maintain its role in ensuring consumer protection, meeting consumers' needs and maintaining coherence of its mission. At present this remit covered areas where there was a direct consumer interest and products were sold directly to consumers.

7. Board members also recognised the very tight time-scale for replies to the interim report consultation and recommended that the FSA used appropriate opportunities for consulting stakeholders before replying formally to the consultation.

8. The Chairman invited Board members to propose additional criteria for consideration at the next Board meeting in January 2005 and invited the Executive to consider the possibility, within the very limited time available, of taking the views of stakeholders on this issue.
Action: Board members to submit proposals to the Secretariat

FSA commitment to sustainable development

9. The Chairman invited Nelisha Wickremasinghe to report on the workshop on sustainability that had been held on 23 November 2004. Nelisha Wickremasinghe reported that four Board members had met with senior FSA officials and five members from the FSA's Think Tank to progress discussion of the FSA's remit for sustainable development. There had been a lively debate on the role of sustainability issues in FSA decision making. Development would continue in terms of providing guidance to officials on how to undertake sustainability assessments, and how the information generated by the assessments would be used. The workshop had concluded that a strong lead was needed. Other Board members who had attended the workshop had been impressed by the quality of the presentations that had been given the members of the FSA's Think Tank and by their enthusiasm.

Item 3 - Chief Executive's Report

Atypical Diarrhetic Shellfish Poisoning (ADSP) test results

10. The Chief Executive reminded Board members that they had received the last report on ADSP issues in May 2004. Since then, the FSA had been working with industry and leading experts in the field, such as Professor Yasumoto (the Japanese world expert on shellfish toxins) and Dr Quilliam (Institute of Marine Biosciences, Canada) to try to understand the problem better. The stakeholder forum established in the autumn met twice, and had generated some very useful suggestions. A standard testing protocol had been established throughout the UK in November 2003 and had been independently audited to ensure compliance. The toxicological work was proceeding, but had been hampered by the lack of positive material, given the relatively low recent prevalence of atypical responses.

11. The Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment (COT) had concluded that the data it had so far considered were suggestive of a neurotoxic mechanism but were not conclusive. The findings of several recent in vitro studies were being evaluated but had also appeared to be inconclusive. Dr Quilliam had agreed to screen material for a much wider range of known toxins than was possible using standard material available in the UK. In the meantime, EU discussions were continuing with the aim of establishing a suitable chemical test replacement for the gold standard mouse test.

12. Board members acknowledged that although unlikely, the knowledge available to date still did not allow a conclusion to be reached as to whether the atypical results were caused by an artefact of the testing method or the presence of a toxin. They agreed therefore that the current precautionary approach remained appropriate. Board members welcomed the research that was being done on replacement tests for the toxins that were already known.

13. Some Board members asked whether there were any shellfish bed restrictions currently in place as a result of this unknown toxin. The Chief Executive informed Board members that, because of the absence of positive results, no restrictions were currently in place due to ADSP.

14. The Chief Executive assured Board members that the FSA would continue to do all he could to resolve the matter conclusively.

Animal by-products investigation

15. The Chief Executive updated Board members on the outcome of the investigations into the potential misuse of category 3 animal by-products reported at the October 2004 open Board meeting. At that time it was known that a Scottish company, Alba Proteins, had been involved in the supply of by-products in the form of animal fats for use as human food. Much of the animal fats had been recovered and disposed of under Local Authority supervision.

16. The investigation into the possibility that 13 outlets had also received category 3 pig intestines from Alba Proteins (not sheep intestines as reported at the October meeting) had shown no evidence of any improper receipt or use of these materials. However, the investigation of a company in the South West of England had shown that animal by-product handling and food processing had not been adequately segregated. The Department for Environment, Food and Rural Affairs (Defra), which is responsible for animal by-products plant licensing, was investigating. Investigations made at the FSA's request by local authorities (LAs) at all renderers and sausage casing manufacturers had not found evidence of any further problems.

17. Following a meeting with stakeholders, the industry had agreed to prepare a Code of Practice on 'other products of animal origin' and the FSA would consider whether there was a need to issue further guidance to enforcers or to tighten the legal controls in this area.

18. Board members welcomed the outcome of the investigations and stressed the importance of the FSA keeping a watching brief on the situation.

FSA Strategic Plan 2005-10

19. The Chief Executive informed Board members that FSA's Strategic Plan for 2005-10 had now been published on the FSA's website. Printed copies of the Plan would be available at the beginning of 2005.

Item 4 - Wall Review of Casualty testing Failures: Next Steps (Paper FSA 04/12/02)

[Prior to the discussion of this item Michael Gibson declared an interest as a primary producer and butcher and Chrissie Dunn declared an interest as a non-Executive Director of a meat marketing company. The Chairman considered that these were not material interests and that Michael Gibson and Chrissie Dunn should participate in the discussion and determination of this issue.]

20. The Chairman welcomed Professor Patrick Wall (University College Dublin ), Chris Lawson (Chief Executive of the Meat Hygiene Service (MHS)) and Peter Hewson (Deputy Veterinary Director), to the table and invited Peter Hewson to introduce this paper.

21. Peter Hewson reminded Board members that the Inquiry into the failure by the MHS to test an estimated 229 casualty cattle aged between 24-30 months for BSE had been initiated by the FSA Board in June 2004. This followed MHS internal audits and management checks that had uncovered these failures. The paper presented for discussion asked Board members to note the actions taken and to agree the further actions planned to address the recommendations made in the Independent Inquiry's report . The plans had been developed with the advice of Patrick Wall's Steering Group. Further progress would be reported to the MHS Governing Board.

22. The Chairman invited Patrick Wall to comment on the actions taken and the actions planned following the report's recommendations.

23. Patrick Wall apologised for not being present at the Board meeting in Belfast to present his report and noted that many of the MHS faults that had been identified by the report had already been highlighted by the MHS and that plans for change had been put in place. The problems identified in the report were similar to many issues faced by big organisations and included accountability issues, monitoring, and supervision and training of staff. Additional issues raised by the report included communications between MHS, FSA and Defra and the need for effective plans to be put in place to improve working relationships across the organisations involved.

24. Board members agreed in general terms with the proposed action plan and were content that Patrick Wall's group had advised on the plan in draft. Some Board members were sceptical of the need to use consultants to address recommendation 4 but were assured this was a targeted exercise, not a root and branch review of the MHS and that experienced consultants could help in progressing the necessary improvements more rapidly. One Board member suggested there was a need to recognise and address the need for both supervision and line management when trying to assist Official Veterinary Surgeons (OVSs) in their work and to reduce their isolation.

25. Board members were supportive of the work conducted by Patrick Wall's group and appreciative of the efforts that had been made to deliver improvements. However, they sought clarity of the roles and responsibilities of the MHS, the FSA and Defra in carrying out regulation and enforcement. Although they recognised the challenges of managing a complex and diffuse organisation such as the MHS, they indicated that they would welcome clearer lines of accountability.
Action: Alick Simmons

26. Referring to recommendations 12 and 13, one Board member stressed the importance of recognising the differences between plants in terms of both staffing and the standards of facilities. He also indicated that he would welcome temporary arrangements to allow those with poor facilities to carry out the necessary improvements.

27. One Board member recommended clarity in ownership of the progress on the action plan and asked that the planned reports to the FSA Board be given by the Chief Executive of the MHS. The Chair of the MHS Governing Board indicated that it was her intention that the Chief Executive of the MHS should always be invited to the table during the presentation of her reports on these issues, and agreed that the Chief Executive of the MHS needed to account directly to the FSA Board for the implementation of the Action Plan.

28. In summary the Chairman noted that the Board had:

• recognised that the failures to conduct the required surveillance had been serious, but had not compromised public safety;
• acknowledged the need to clarify the lines of accountability and responsibility and to define better the roles and interactions between the MHS, the FSA and Defra;
• raised issues of detail regarding the action plan, which would need to be addressed by the MHS, including training and development of OVSs;
• noted that the situation in Northern Ireland would need to be addressed in the same way as the rest of the UK, whilst taking into account the differences in responsibilities for enforcement in licensed meat premises; and
• noted that implementation of the recommendations would present a challenge for the MHS and the target dates for these changes would need to be kept under review.

Item 5 - Review of Over Thirty Month Rule, Progress Report on Assessment of Robustness of the Proposed BSE Testing Regime (Paper FSA 04/12/03)

[Prior to the discussion of this item Michael Gibson declared an interest as a primary producer and butcher. The Chairman considered that this was a material interest and that Michael Gibson should not participate in the discussion and determination of this issue. Michael Gibson left the table for this item. Chrissie Dunn declared an interest as a non-Executive Director of a meat marketing company. The Chairman considered that this was not a material interest and that Chrissie Dunn should participate in the discussion and determination of this issue.]

29. The Chairman invited David Carruthers, Head of Over Thirty Months (OTM) Branch, to the table to join Professor Patrick Wall and the Chief Executive of the MHS and to introduce this paper.

30. David Carruthers reminded Board members that the Government had recently announced the start of a managed transition towards the lifting of the over thirty months (OTM) rule and its replacement with a robust system of BSE testing. That announcement, made on 1 December, had made clear that the final switch from the OTM rule to testing should happen only when the FSA had advised Ministers that the BSE testing system would be robust. Ministers had agreed that the FSA should have a new ongoing responsibility for the review and audit of the testing system as a whole. The FSA would also be responsible for consulting on draft legislation to replace the OTM rule.

31. In September 2004, Board members had agreed that an independent group, drawn from the group investigating the casualty testing failures, should be set up to assist the FSA in providing advice on the robustness of the proposed BSE testing system. The independent group's membership had been expanded to include two additional experts: Professor Peter Lind (a member of the European Food Safety Authority's Scientific Expert Group on TSE Testing) had joined as an expert on testing in Europe and Dr Geoff Spriegel (until recently Technical Director of Sainsbury's Supermarkets) had joined as an expert on quality control.

32. Following the Board's discussions in September, stakeholder involvement in the process had been re-established and a successful stakeholder meeting had been held on 6 December 2004 at which no organisation had reacted unfavourably to the decision to move towards rule change. The meeting had also provided an opportunity for Professor Patrick Wall and other members of his team to make clear, in front of stakeholders, that they would be independent, rigorous and that consumers' interest would come first. Also, the FSA's Consumer Committee had considered this issue at its meeting on 16 September and had asked that full scale trials of the testing system be carried out.

33. The Chairman invited Professor Patrick Wall to present the initial report of the independent group (Annex C to the paper). Professor Wall noted that the aim of the group had been to design a system and monitoring programme and that they had been looking at systems already in place in several European Countries. The group would be considering only those issues related to the establishment of a robust testing regime. They would not be responsible for other considerations, such as value for money and risk assessment. Professor Wall also stressed the importance of 100% compliance and of learning from the experiences of other countries in the initial establishment of similar testing regimes.

34. The Chairman asked about the scale of the trials required to demonstrate the robustness of the new testing regime. The initial trials, which would be equivalent to several days' production runs at full capacity, would be followed by specific trials at premises that had shown an interest in switching to the new regime. Training of staff to comply with the new testing system would also be required.

35. Board members agreed that aiming for 100% compliance with the new testing regime would not be negotiable but accepted that human error would occur and needed to be recognised. They also agreed that a system should be put in place to identify, and immediately address, the occurrence of such failures.

36. Some Board members asked about the reported difficulties in recruiting a DH nominee to the group. The Chief Executive informed Board members that there had been practical problems in recruiting suitably qualified members, as the experts proposed by DH were already fully engaged on other issues, but additional experts were now being sought and would join the group.

37. Professor Wall agreed with the comments made by some Board members that the current instructions would need to be reviewed following trials and possibly would need to be less prescriptive to allow room for professional judgement depending on different environmental conditions.

38. Some Board members requested a short note on the experiences of other member states in introducing BSE testing.
Action: David Carruthers

39. Some Board members asked about funding arrangements for the new testing system. The FSA Chief Executive confirmed that the Chief Executive of the MHS would be responsible for identifying additional MHS requirements in Great Britain. It would be the responsibility of the FSA Chief Executive himself to ensure that adequate funding to meet these additional requirements was negotiated with Defra. In Northern Ireland, funding would need to be negotiated with the Department of Agriculture and Rural Development (DARD).

40. The Chairman summarised the main points raised in the discussion. The Board had:

• approved the initial report of the independent group, with this now leading to a full trial of the testing systems (rather than, as the Board paper implied, this initial approval being subject to a full trial);
• noted that the work of the independent group chaired by Professor Wall constituted the initial step in the process of establishing a robust testing system;
• agreed that aiming for 100% compliance of the new testing regime would not be negotiable, but accepted that human error would occur and there was a need to put in place effective controls to identify and address such errors and to communicate risks to consumers;
• recognised the difficulty of complying with the current timetable and agreed to review it if necessary; and
• asked for a short note on the experiences of other member states in introducing BSE testing.

Item 6 - BSE and Sheep Contingency Policy (Paper FSA 04/12/04)

[Prior to the discussion of this item Michael Gibson declared an interest as a primary producer and butcher and Chrissie Dunn declared an interest as a non-Executive Director of a meat marketing company. The Chairman considered that these were not material interests and that Michael Gibson and Chrissie Dunn should participate in the discussion and determination of this issue.]

41. The Chairman invited Alan Harvey, Head of Transmissible Spongiform Encephalopathies (TSE) Division, to introduce the paper. Alan Harvey noted that the Board had last looked at the position on BSE and sheep in June 2002, following consideration by a core stakeholder group, together with scientific experts. The purpose of this paper was to provide an update on what had been happening since then and to consider the current FSA policy in the light of that information. Board members were reminded that there were still no findings of naturally occurring BSE in sheep in the UK. However, the possibility of a small self-sustaining BSE epidemic in a few flocks could not be ruled out as a hypothesis.

42. Some progress had been made on the science and the position on testing had been set out in Annex A of the paper. The Spongiform Encephalopathy Advisory Committee (SEAC) had recently concluded that the test to discriminate between BSE and scrapie, which was not thought to be transmissible to humans, was now more robust. The effects of controls were very different in sheep than in cattle: whereas with cattle, the removal of specified risk material (SRM) took away over 99% of infectivity in any animal incubating BSE, the position for SRM removal in sheep was much less straightforward, to such an extent that any BSE infected sheep would represent a far higher infectious load going into the food chain, perhaps by a factor of over a thousand times, than a bovine equivalent.

43. Investigations were currently underway in relation to the possibility that a French goat may have BSE.

44. The UK was not alone in scoping the question of contingency planning in case BSE were to be found in sheep and goats: the EU was actively engaged with this. The European Commission would expect a harmonised approach to be followed in the event of a positive finding in any member state.

45. The policy agreed by the Board in 2002 was that, in the event of a BSE finding in sheep, only resistant and semi-resistant sheep under 12 months would be allowed to enter the food chain. In the absence of practical means to identify such sheep, this would, in practice amount to the loss of an entire year's lamb crop. Paragraph 31 of the paper referred to Defra's plans to permit progressive restocking after any such loss using only fully resistant rams. The paper proposed that, for the time being, the present policy should remain in place, subject to any overarching EU measures being introduced. It also proposed to continue discussions on proportionality with stakeholders and then return to the Board in the autumn of 2005.

46. The Chairman noted that the Board had been briefed in November 2004 by the Chair of SEAC on the current situation with regard to BSE and sheep and BSE and goats. The present discussion was aimed at agreeing a contingency plan in the light of reduced uncertainties. The FSA did not currently advise consumers to avoid any product from sheep or goats and he explained that this had not changed.

47. Board members noted (Annex D to the paper) that SEAC had stressed that the risk of finding BSE in sheep was very low and that, since the Board last consideration of the issue in 2002, more sheep had been tested and no BSE cases had been found. However, the dose of potentially infected material in a single sheep, and therefore the potential transmission from sheep to humans, would be much higher than from cattle to humans. Further, the degree of resistance of genetically resistant and semi-resistant animals was not clear.

48. Some Board members questioned whether further work was needed on testing of goats. An EU working group had been set up to consider the possible extension of specified risk material rules to goats and to increase the level of testing. Risk management issues would be discussed at EU level should BSE be confirmed in the atypical case French goat.

49. Most Board members agreed with the proposal to review the current position in the autumn of 2005 but stressed the importance of timely notification of abnormal results and scientific advances in order to be able to review the situation promptly in the interim if required.

50. Board members agreed with the importance of involving stakeholders in the development of contingency plans for sheep and in clarifying the need for parallel contingency plans for goats.

51. One Board member expressed concern that a tracking system similar to cattle had not yet been developed for sheep. It was agreed that this concern would be forwarded to Defra.
Action: Alan Harvey

52. The Chairman summarised the main points raised in the discussion. The Board had:

• noted that the discussion had addressed a possible risk since there was no indication of BSE occurring spontaneously in any UK sheep or goat;
• noted that the discussion had not lead to any change in the current FSA advice for consumers with regards to the consumption of sheep and goat produce;
• agreed the present contingency policy subject to any overarching EU measures being introduced;
• stressed the importance of consumer protection and proportionality in any risk management measure;
• noted the need for distinct approaches for sheep and for goat;
• agreed with the need for further discussion on proportionality with stakeholders, including industry and consumer groups; and
• agreed with the need of a prompt review of the FSA contingency plans in the light of any new research results.

Item 7 - Report from the Chair of the MHS Governing Board (Paper FSA 04/12/05)

53. The Chairman welcomed Chrissie Dunn, Chair of the MHS Governing Board, and Chris Lawson to the table and invited Chrissie Dunn to report on the progress of the establishment of the MHS Governing Board and on its first meeting in November 2004.

54. The Chair of the MHS Governing Board thanked Valerie Howarth for having agreed to be Deputy Chair of the MHS Governing Board and Maureen Edmondson and Richard Ayre for accepting the additional commitment and responsibility of becoming members of the MHS Governing Board. She also noted that the representation provided by Jon Bell (FSA Chief Executive) and Alick Simmons (FSA Veterinary Director) added considerably to the value of the discussions at meetings. Advertisements to recruit external members would be published at the beginning of January 2005.

55. The Chair of the MHS Governing Board had completed a number of visits to licensed meat plants and MHS offices across the UK. She had gained a better understanding of the MHS and of the meat industry as a result, and encouraged other Board members to do the same.

56. The existing MHS Audit and Risk Committee arrangements had been clarified and the Chair of the MHS Governing Board emphasised that she was totally satisfied with them.

57. One Board member noted that the minutes of the last meeting of the Meat Hygiene Advisory Committee (MHAC) had not been circulated and approved and asked that this be done before the next meeting of the MHS Governing Board.
Action: Vanessa Charles

58. The Chairman thanked the Chair of the MHS Governing Board and the other FSA Board members on the MHS Governing Board for taking on their roles.

Item 8 - Reports from Chairs of Advisory Committees (Papers FSA 04/09/06, FSA 04/09/07 and FSA 04/09/08)

Wales

59. The report from the Chair of the Welsh Food Advisory Committee (WFAC) was accepted.

Scotland

60. The Chair of the Advisory Committee for Scotland (SFAC) informed Board members that SFAC had reviewed of its past performance at a recent retreat and had also discussed the new FSA Strategic Plan. He added that the names of suitable candidates for the current SFAC vacancies had been submitted to Ministers and that announcements were expected in the near future. Due to the large number of new members, SFAC had planned a mentoring programme.

Northern Ireland

61. The Chair of the Northern Ireland Food Advisory Committee (NIFAC) informed Board members that four members would retire in July 2005 and advertisements for these vacancies would be published in early January 2005.

Item 9 - 'White Paper on Public Health: Choosing Health' and the FSA's Strategic Plan 2005/10 (Paper FSA 04/12/09)

62. The Chairman invited Board members to comment on the paper tabled at the meeting, which outlined the areas of the recently published White Paper on Public Health that are of particular interest to the FSA.

63. Board members agreed that it would have been useful to compare the recommendations made by the FSA on initiatives such as children's diets and nutrition, with the issues that had been included in the White Paper. This would have provided a measure of the FSA's influence in these areas.

64. Most Board members agreed that the White Paper indicated a general intention to improve cross-government relationships and showed that many of the ideas developed by the FSA and other interested organisations had been successfully incorporated into government policy.

Any Other Business

65. There was one item of other business:

Update on delivering the Agency's Research Strategy (Michael Gibson) (paper INFO 04/12/01)

66. Michael Gibson asked for a more detailed paper on the FSA Research Strategy to address in particular the decision mechanisms and the setting of priorities for research. The Chief Executive informed Board members that the present information paper had been intended as an interim report to be followed, in the second half of 2005, by another paper addressing the alignment of the portfolio with the new Strategic Plan and prioritisation of research.

Date of Next meeting

67. The next open meeting would be held on 9 February in London.